Design Controls Engineer

Job Title – Design Controls Engineer
 
Duration- 3 months – Likely to extend
 
Location - Maple Grove MN
 
Role - 
You will be supporting R&D integration efforts, including the deployment of the Product Development, Launch and Maintenance (PDLM) processes within Research and Development (R&D). Activities include comparative assessments of current state to PDLM, working with functional Subject Matter Experts (SME’s) to develop adoption plans, developing Standard Operating Procedures and templates, collaborating with key stakeholders and releasing documentation.
 
 What Success Looks Like:
 • Independently compare current state processes to PDLM process and recommend adoption plans.
 • Collaborate with R&D SME’s and cross-functional stakeholders to develop adoption strategies. 
 • Drafting or revising Standard Operating Procedures that incorporate PDLM framework into existing processes.
 • Contributes critical thinking to create robust documentation, identifies where interdependencies between processes or functions exist and elevates to appropriate SME’s and Project Manager.
 • Able to lead change reviews with key stakeholders and accurately capture and address input from reviewers to maximize first time approval of Engineering Change Orders.
 • Coordinating training to support release of new or revised R&D documents.
 • Tracks and reports progress and will communicate any identified risks or delays to projects.
 
 Desired Experience:
 • B.S. of Mechanical, Chemical, Industrial, Materials or Biomedical Engineering or similar field 
 • 3+ years of experience working within Design Controls in product development of Medical Devices as a Quality Engineer or Development Engineer. 
 • Must have experience in applying Design Controls and Risk Management using a life cycle approach. 
 • Working knowledge of 21 CFR 820, ISO 13485, and ISO 14971. 
 • Technical writing experience, including writing procedures, creating templates for project deliverables and documenting supporting rationale.  
 • Leading implementation of changes including document review, Engineering Change Orders, and coordination of training. 
 • Experience with MS Work, MS Excel and MS PowerPoint. 
 • Ability to travel up to 50%.
 
Top 3 Desired Attributes for Candidates:
  • 3+ years of experience working within Design Controls in product development of Medical Devices as either a Quality Engineer or Development Engineer.
  • Technical writing experience, including writing procedures, creating templates for project deliverable and documenting supporting rationale. 
• Collaborate with R&D SME’s and cross-functional stakeholders to develop adoption strategies.
 
Best,
Kushal Shah
APN Software Service INC
kushal@apninc.com

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